Becton, Dickinson issued a statement on the safety of its paclitaxel-coated devices following a June 19-20 FDA advisory committee meeting that heard arguments for and against such products.
The Medical Devices Advisory Committee’s panel on circulatory system devices discussed the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease in the superficial femoropopliteal artery (SFA).
The panel found “strong evidence of benefit and recommended additional efforts to evaluate long-term safety” of the products, BD noted. The company presented its own data, arguing it confirmed that the benefits outweigh the risks for Lutonix drug-coated balloons (DCBs) in SFA.
“BD continues to stand behind the safety” of its Lutonix drug-coated balloons,” the company said, adding that it will “ continue to collaborate with FDA, industry and professional organizations to collect and analyze data for the benefit of patients.”